Evergreening is a misconception

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For Novartis VC and MD Ranjit Shahani the battle over Glivec has been a long waiting game. He tells TOI-Crest that if the company is not successful in securing a patent in India it would have a chilling impact on foreign direct investments and R&D

Why is Novartis fighting the case in India when there are already generic versions being sold in the country?

Novartis is seeking clarity on the patent law in India. Knowing we can rely on patents in India benefits government, industry and patients because research-based organizations will know if investing in the development of better medicines for India is a viable long-term option.

As a major manufacturer of generics, Novartis understands and recognises the contribution of generics once drug patents expire;our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical research and development. Patents provide an incentive to the pharmaceutical industry to invest in the development of new medicines to treat diseases that are currently untreatable, incurable or in need of new treatment options, and provide treatment when patients develop resistance to older drugs. Without pharmaceutical research and development leading to innovative medicines, poor people will continue to suffer.

The argument being used against Novartis and its fight for Glivec is that the company is 'evergreening' the patent. Please comment.

Novartis takes the view that Section 3(d), the Indian legal paragraph intended as a hurdle for "evergreening", is not applicable at all to the breakthrough medicine Glivec whose chemical name is imatinib mesylate. It has been widely recognised as one of the major medical breakthroughs of the 20th century. It has revolutionised the way certain cancers are treated.

The beta crystal form of imatinib mesylate is the active ingredient of the genuine breakthrough medicine, Glivec. No other drug comprising imatinib was available anywhere in the world before Glivec was launched. Scientists at Novartis developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionised cancer treatment. The patent filing claiming the beta crystal form of imatinib mesylate relates to the genuine product and represents the very first patent right filed in India claiming Glivec. If you ignore these facts you arrive at the misconception of 'evergreening'.

The case has grabbed headlines all over the world, with implications on domestic industry, MNCs and patients. What if Novartis loses?

We welcome the opportunity to present our case to the Indian Supreme Court and have confidence that the Court will make the right decision based on the law of India. Novartis has a portfolio of more than 130 projects in clinical development and invested $9. 6 billion in research in 2011. In oncology alone, there are 25 new medicines in development, more than 1, 13, 000 patients in clinical trials and over 30 drugs ongoing Phase 3 or pivotal studies, the last step before seeking regulatory approval of a potential new medicine or new use of an existing medicine. The success of medicines that reach the market support this enormous research effort.

Once innovative medicines reach the end of their patent life, the innovation is "released" to the healthcare systems and generic manufacturers are then able to produce and supply the medicine at a very low cost. This cycle of innovation to generic supports medical advancement for people suffering with diseases that either lack treatments or need new options as resistance develops to existing treatments.

And the implication for the pharmaceutical industry, if it does win the case?

We would like to stress that the outcome of the case will not hinder the supply of essential medicines because international trade agreements include safeguards to ensure access and our legal case does not challenge these provisions. As the second-largest manufacturer of generics in the world, Novartis fully understands and recognises the contribution of generics once drug patents expire;our concern is with the non-recognition of intellectual property rights.

Through this case we are advocating medical progress through innovative drug research that targets diseases without effective treatments. Patents are the primary incentive supporting development of new medicines and without them investment in R&D will plummet. The problem of lack of access to medicines goes far beyond the simple availability of generic drugs. Poor people in developing countries will suffer needlessly until a wide variety of issues such as lack of diagnosis, infrastructure and distribution are solved.

Novartis is deeply committed to supporting access to medicines as evidenced by our many initiatives such as the Glivec International Patient Assistance Program - which provide 95 per cent of patients - 15, 000 patients - in India on Glivec with free medicine - and we are willing to work with governments, NGOs and others to find innovative solutions to the challenge of access.

Patient advocacy groups say that the win will be detrimental to their interests. What's your response to that?

Novartis fully supports flexibilities in the international trade agreement that provide for countries like India to make exceptions to patent rights. These provisions allow a government to issue a compulsory license to other companies to produce pharmaceuticals in case of a national health crisis. We are not challenging these provisions. Novartis actively supports other ways to increase access, such as public-private partnerships, tiered pricing arrangements and shared contribution models in addition to donation programmes.

Our legal action will in no way impact access to medicines to poor countries. Some groups are confusing the issue by drawing conclusions that the case will affect essential generic medicines produced in India for the developing world. HIV/AIDS medications, like all other pharmaceutical products, have been patentable in India since 2005. Most second-line AIDS medications are new chemical entities (NCEs), and therefore patentable in India.

Furthermore, independent of the legal outcome in our case, the current generic drugs will continue to be available in India because of the grandfather clause transition system.

Medicines can be made available through access safeguards in international agreements and, in the case of essential and life-saving medicines, special pricing arrangements in developing countries can, and must, be made. This is often true in the case of HIV/AIDS medications. However, more attention should be paid to other barriers to access - especially in India, where less than 7 per cent of the population needing antiretroviral therapy receives it.

In which countries does Glivec have patent protection rights?

It has a patent in 40 countries, including China, Russia, Mexico, Taiwan, and all major developed countries. There is only one Glivec.